Court Decides to Shut Down Deltex for Noncompliance With GMPs

A federal court has ordered Deltex Pharmaceuticals, its president, Kabir Ahmed, and vice president, Mohidur Khan, to immediately cease all operations pending full compliance with FDA requirements following repeated cGMP violations.

In addition, the contract manufacturer must recall and destroy all prescription and OTC drugs produced at its Rosenberg, Texas, plant since Oct. 31, 2008, and advise its clients to recall products in retail stores as part of the permanent injunction.

The injunction, issued by the U.S. District Court for the Southern District of Texas, was requested by the FDA following repeated warnings to Deltex regarding adulterated and misbranded drugs and failure to comply with cGMP regulations.
Drug GMP Report